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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12. 09. – 27. 09. 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was carried out in accordance with internationally valid GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
[1,1'-binaphthalene]-2,2'-diol
EC Number:
606-048-4
Cas Number:
18531-94-7
Molecular formula:
C20H14O2
IUPAC Name:
[1,1'-binaphthalene]-2,2'-diol

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: breeding farm VELAZ s.r.o., Koleč u Kladna, Czech Republic
- Age at study initiation: 8-10 weeks at the time application
- Weight at study initiation: 149 - 178 g
- Fasting period before study: 20 h
- Housing: animal room with monitoring conditions – 3 animals of one sex in one plastic breeding cage
- Diet (e.g. ad libitum): ST 1 BERGMAN – standard pelleted diet
- Water (e.g. ad libitum): drinking tap water
- Acclimation period: 12 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C, permanently monitored
- Humidity relative (%): 30 – 70 %, permanently monitored
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): light period 12-hour light/12 hour dark

IN-LIFE DATES:
Animal supply: 31. 08. 2011
Experimental part of study: 12. 09. - 27. 09. 2011

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0,5% Methylcelulose in aqua pro injectione
Details on oral exposure:
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Test procedure with a starting dose of 2000 mg/kg was selected according to EU Method B.1 tris Annex 1D.
START: 2000 mg/kg – 3 females (Step No.1): no deaths ► 2000 mg/kg – 3 females (Step No. 2): no deaths ► END of study
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 females per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

- Time schedule of observations:
- Body weight: before application, the 8th day and before euthanasia of animals
- Mortality: daily
- Clinical examination: daily
- Pathological examination: 15th day

- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
The test substance administered at the dose of 2000 mg/kg caused no death of animals.
Clinical signs:
other: No clinical signs of intoxication were observed after application in all six animals.
Gross pathology:
No pathologic macroscopic changes were diagnosed during pathological examination.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the study results the value of LD50 of the test substance, (R)-(+)-1,1´-Bi-2-naphthol, (in female rats) is higher than 2000 mg/kg of body weight.
Executive summary:

The aim of the study was to investigate acute toxic effects of the test substance, (R)-(+)-1,1´-Bi-2-naphthol, after a single oral administration to Wistar rats.

The testing was performed according to the Method B.1 tris: Acute Oral Toxicity - Acute Toxic Class Method, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.

The test substance was administered in a single dose as suspension in vehicle (0.5% methylcelulose), given orally via gavage to groups of three female Wistar rats.

The dosing was performed sequentially in two groups of three females: group No. 1 - first step using the starting dose of 2000 mg/kg of body weight and group No. 2 - second step using the same dose.

The test substance administered at the dose of 2000 mg/kg caused no death of animals.  

No clinical sign of intoxication were observed after application in all six animals.

No pathologic macroscopic changes were diagnosed during pathological examination.

According to the study results the value of LD50 of the test substance for female rats is higher than 2000 mg/kg of body weight.